Quality control device for solid, pharmaceutical products

ABSTRACT

The invention relates to a device ( 17 ) for the quality control of solid pharmaceutical products such as tablets, comprising a testing means ( 9 ) having a sensor for checking one or more parameters of the products. The device ( 17 ) consists of a housing ( 2 ) and a test chamber ( 15 ) that is arranged above said housing ( 2 ) and that is formed by a floor ( 4 ) and by a protective hood ( 1 ) that is placed onto this floor, whereby testing means ( 9 ) are located in said chamber. Drives ( 14 ) and, if applicable, supply means for the testing means and the transporting means ( 5, 6, 7 ) that are arranged in the test chamber ( 15 ) are located in the separate housing ( 2 ) encapsulated so as to be at least splash-proof and dust-tight vis-à-vis the test chamber ( 15 ) and the environment. At least parts of the feed lines ( 11 ) leading to the drives and the supply lines that provide energy to the testing means inside the housing ( 2 ) pass to the outside of the sealed test chamber ( 15 ) in an encapsulated manner so as to likewise be splash-proof and dust-tight.

TECHNICAL FIELD

The invention relates to a device for the quality control of solidpharmaceutical products such as tablets, pills, oblongs and the like,comprising at least one testing means and at least one transportingmeans as well as at least one sensor—such as scales and/or heightmeasuring means and/or force measuring means for measuring the weightand/or the thickness and/or the rupture strength of the product—forchecking and ascertaining one or more parameters of the individualpharmaceutical product, said device being of the type described in themain claim.

STATE OF THE ART

Devices for the quality control of solid pharmaceutical products suchas, for example, tablets, pills, oblongs and the like are known in whichproducts are fed individually to various testing means that check, forexample, the weight, hardness, dimensions, abrasion properties and thelike. In a known device of the generic type for quality control, whichhas a test chamber formed by a protective hood that can be lifted off,homogeneous, solid pharmaceutical products are poured into a storagecontainer, from where they go to a singling trough at whose end theproducts are individually picked up by a loading means and are eachplaced by the loading means into a receiving cell of a star feeder thatis open towards the test chamber floor. This star feeder can rotatearound its vertical axis and is arranged at a small distance parallel toand above the test chamber floor, so that the product lying in thereceiving cell cannot end up in the gap between the star feeder and thetest chamber floor. While in the receiving cell of the star feeder, theproduct is conveyed to the weighing platform of scales that are arrangedflush in the test chamber floor, for example, in order to determine theweight of the product, and the product is subsequently removed from thereceiving cell through a discharge opening located in the test chamberfloor, said cell being arranged radially at a distance from themid-point of the star feeder, so that the rotation of the star feedercauses the receiving cell to move from the scales to above the dischargeopening and then the product contained in the receiving cell fallsthrough the discharge opening into a channel that ends above acollecting container, where the tested products can be collected, forinstance, for the next testing or checking procedures.

Typically, such a device is employed for the quality control of solidpharmaceutical products for checking procedures that are carried outconsecutively on various pharmaceutical products. For this purpose,products are regularly removed from the ongoing production and collecteduntil a sufficiently large number is available for a quality controlrun.

In order to prevent subsequent quality tests such as, for instance, ananalysis of the active ingredients, from being falsified due to dust orother residues from products that were previously tested in the samedevice, it should be possible to clean the testing means very thoroughlyprior to every test run. This is particularly important for combinationdevices where, in addition to weighing, for example, also hardnesstesting, thicknesses measurements and the like are conducted, wheneverthe same device is used for the quality control of other productsfollowing hardness tests during which the products are destroyed.

Cleaning such devices is time-consuming since sensitive components suchas, for instance, the scales, the controls for the singling trough, thecontrols for the loading means, the storage means and the like, whichare employed to detect and record measured data as well as theappertaining sensors, are situated in the test chamber that is to becleaned or else the components have openings facing in the direction ofthe test chamber, so that the operating personnel must be very carefulto avoid damage to components, particularly damage caused by cleaningsolutions, cleaning materials such as cloths, and the like.

Known devices for quality control of the generic type also entail thedraw-back that the feeding, singling, testing and collecting of theproducts as well as the recording of the acquired test data all takeplace in one device at its set-up location.

German patent application DE 100 24 598 A1 discloses a device for theautomatic quality control of test specimens such as tabs, tablets, pillsor dragées for purposes of determining their mechanical-physicalproperties such as the weight, dimensions, disintegration time in amedium as well as hardness. The device consists of a feed means and astar feeder with peripherally arranged receiving chambers for one testspecimen each and a hardness tester, if applicable, a set of scales aswell as a means to determine the dimensions of the test specimen,whereby a linear conveyor is connected to one outlet of the star feederfor purposes of taking over the test specimen, said linear conveyorbeing followed by the hardness tester and being arranged so as to betangential to the star feeder. The device has a data processing unitthat acquires and processes all data by means of a main processor and anauxiliary processor that cooperates with the main processor in order tocoordinate the movement of the hardness tester with the running starfeeder.

Technical Objective of the Invention

Therefore, the invention is based on the objective of creating a devicethat serves for the quality control of solid pharmaceutical products,that can be cleaned quickly and particularly thoroughly so as to shortenthe change-over times when a switch is made to other products and thatallows an evaluation of the obtained test data at any other desiredplace, in other words, irrespective of where it is located. Thus, it isthe aim of the invention to provide a device that can be cleanedthoroughly and quickly as well as automatically and that also makes itpossible to forward data remotely.

Disclosure of the Invention and its Advantages

This objective is achieved according to the invention by means of adevice for the quality control of solid pharmaceutical products such astablets, pills, oblongs and the like, comprising at least one testingmeans that has at least one sensor—such as scales and/or heightmeasuring means and/or force measuring means for measuring the weightand/or the thickness and/or the rupture strength of the product—forchecking and ascertaining one or more parameters of the individualpharmaceutical product, and also having a transport means for theproducts, characterized in that the device has a housing and a testchamber that is arranged above said housing and that can be sealed so asto be splash-proof or water-tight and dust-tight vis-à-vis theenvironment, said chamber being formed by a floor and by a protectivehood that can be placed onto and lifted off this floor, whereby thetesting means as well as the transporting means are located in saidchamber.

lifted off this floor, whereby the testing means as well as thetransporting means are located in said chamber.

According to a variant of the invention, the protective hood can beconnected in a detachable manner to the test chamber floor so as to besplash-proof or water-tight and dust-tight.

According to another variant of the invention, the protective hood canbe pressed onto the periphery of the test chamber floor and locked inplace so as to be splash-proof or water-tight and dust-tight, wherebythe protective hood has an encircling gasket that is splash-proof orwater-tight and dust-tight on its surface facing the test chamber floor.

The device according to one of Claims 1 to 3, characterized in that thehousing can likewise be sealed so as to be splash-proof or water-tightand dust-tight.

According to another variant of the invention, means for driving,controlling and supplying one or more testing means and one or moretransporting means are arranged in the housing.

According to another variant of the invention, all of the lines and/ordrive shafts leading into or out of the test chamber are configured soas to be splash-proof or water-tight and dust-tight as they pass throughthe protective hood or the floor.

According to another variant of the invention, the floor has at leastone passage, especially for passing lines or a drive shaft through, saidpassage being sealed by means of a gasket that is splash-proof orwater-tight and dust-tight.

According to another variant of the invention, the gaskets areinflatable O-ring gaskets.

According to another variant of the invention, all inlet or feedopenings leading into the test chamber as well as all outlet ordischarge openings leading out of the test chamber can be hermeticallysealed so as to ensure that the test chamber is splash-proof orwater-tight.

According to another variant of the invention, the test chamber flooris, at the same time, the wall of the housing.

According to another variant of the invention, means for driving,controlling and supplying the testing means and the transporting means,such as drive aggregates, electric motors, electric controls, signalamplifiers as well as electric and/or optical and/or mechanicalconnections to supply energy to the testing means are all arrangedinside the housing.

According to another variant of the invention, an interface that isaccessible from outside of the housing is arranged on the housing,preferably on its front wall, whereby a plurality of electric linesleading into or out of the housing open into said interface and thelatter serves to establish an electric connection for the device and/orto transmit electric signals and/or data between the device and theoutside world.

According to another variant of the invention, a hinged door is arrangedon the housing in such a way as to form an antechamber between thehousing and the hinged door.

According to another variant of the invention, the device encompassesthe following additional components:

-   -   a singling means as part of the transporting means arranged        inside the test chamber, whereby the pharmaceutical products can        be fed from the storage container to the singling means;    -   a conveying means as another part of the transporting means that        is arranged above the test chamber floor and that has at least        one receiving cell open towards the floor into which one product        from the singling means can be introduced, whereby the product        accommodated in the receiving cell can be fed to the testing        means;    -   a discharge opening to which the product—after it has been        tested by the testing means—can be fed during the further course        of transportation by the conveying means, whereby the product        reaches the discharge opening and then falls through it, as a        result of which it is removed from the receiving cell;    -   as well as a collecting container situated below the discharge        opening that serves to receive the tested products or parts        thereof once they have fallen through the discharge opening.

According to another variant of the invention, the transporting means isa star feeder that is arranged parallel to the floor and that can rotatearound a vertical axis, whereby the receiving cell is situated in thevicinity of the outer circumference of the star feeder and whereby thetesting means as well as the discharge opening are arranged in such away that, as the star feeder turns in its direction of rotation, eachproduct accommodated inside the receiving cell first reaches the testingmeans and subsequently the discharge opening.

According to another variant of the invention, the discharge opening isa hole in the test chamber floor, whereby the collecting container islocated in the antechamber.

According to another variant of the invention, the test chamber floorhas a rim around the discharge opening.

According to another variant of the invention, the testing means is aset of scales equipped with a weighing platform and a load cell.

According to another variant of the invention, the inside of the housingcan be charged with positive pressure relative to the environment and/orto the test chamber.

According to another variant of the invention, the test chamber can becharged with negative pressure relative to the environment.

According to another variant of the invention, the housing is situatednext to the test chamber floor rather than below it.

According to another variant of the invention, the device has rollers orwheels on which the device can be moved.

According to another variant of the invention, the front wall of thehousing consists of a frame and of a removable front plate that can beplaced onto the frame so as to be water-tight.

According to a variant, the device according to the invention for thequality control of solid pharmaceutical products such as tablets, pills,oblongs and the like comprises at least one testing means that has atleast one sensor—such as scales and/or height measuring means and/orforce measuring means for measuring the weight and/or the thicknessand/or the rupture strength of the product—for checking and ascertainingone or more parameters of the individual pharmaceutical product, wherebythe device consists of a housing with a test chamber that is arrangedabove said housing and that is formed by a floor and by a moveableprotective hood that can be placed onto this floor, whereby the testingmeans as well as the transporting means are located in said chamber,whereby the drives and, if applicable, supply means for the testingmeans and the transporting means that are arranged in the test chamberare, in turn, located in the separate housing encapsulated so as to beat least splash-proof and dust-tight vis-à-vis the test chamber and theenvironment and whereby at least parts of the feed lines leading to thedrives and the supply lines that provide energy to the testing meansinside the housing pass to the outside of the test chamber in anencapsulated manner so as to likewise be at least splash-proof anddust-tight.

According to another variant of the invention, the feed lines leading tothe drives and, if applicable, to the supply means that provide energyto the testing means and to the transporting means pass through the testchamber floor into a receiving chamber located below the sealed testchamber and formed by the housing, so that the device is divided by thetest chamber floor into the test chamber and into the receiving chamberof the housing, whereby the housing that encloses the receiving chambercan likewise be closed by a door or the like so as to be water-tight anddust-tight, and the means for driving, controlling and supplying thetesting means and the transporting means, such as drive aggregates,electric motors, electric controls, signal amplifiers as well aselectric and/or optical and/or mechanical connections to supply energyto the testing means are all arranged inside the receiving chamber.

According to another variant of the invention, the housing of thereceiving chamber has at least one interface that is accessible fromoutside of the housing, preferably in the front wall of the housing, andthat serves to establish a connection for electric and/or optical and/ormechanical connections for supplying energy to the testing means and forconnecting a computer or the like for function monitoring as well as fordetecting and forwarding test data from the sensors, so that the devicecan be controlled and the test data can be evaluated irrespective of theset-up location of the device.

According to another variant of the invention, the protective hood canlikewise be pressed onto the periphery of the test chamber floor andlocked in place so as to be water-tight and dust-tight.

According to another variant of the invention, the protective hood hasan encircling gasket on its surface facing the test chamber floor.

According to another variant of the invention, the test chamber floor aswell as the protective hood extend beyond the housing of the receivingchamber on at least one side, preferably the front of the housing,whereby a hinged door is arranged on the housing and it separates offanother chamber below the floor and between the front of the housinglocated across from the hinged door, namely, the antechamber into whichthe interface opens that is accessible from the outside.

According to another variant of the invention, the device has a singlingmeans arranged inside the test chamber, to which singling means thepharmaceutical products can be fed from a storage container, whereby thedevice has a transporting means that is arranged above the test chamberfloor and that has at least one receiving cell open towards the floorinto which one product from the singling means can be introduced,whereby the product in the receiving cell is fed to at least one testingmeans that is preferably located below the transporting means and thatchecks the product in terms of its weight and/or dimensions and/orhardness and/or abrasion properties, and the product—after it has comefrom the testing means—is removed from the receiving cell via adischarge opening located in the floor into which the product falls overthe further course of transportation after being tested, whereby acollecting container is situated below the discharge opening that servesto receive the tested products or parts thereof.

According to another variant of the invention, the transporting means isa star feeder that can rotate around its vertical axis and that has atleast one receiving cell on its outer circumference and, in itsdirection of rotation, the testing means comes first, followed by thedischarge opening in the direction of rotation.

According to another variant of the invention, the discharge opening islocated in the part of the test chamber floor that extends beyond thehousing of the receiving chamber, whereby the collecting containersituated below the discharge opening is located in the additional freespace that is separated off by the hinged door.

According to another variant of the invention, the testing means is aset of scales equipped with a weighing platform and a load cell, wherebythe weighing platform is arranged above the test chamber floor and thefloor under the weighing platform has a rim, and the weighing platformhas a recess to receive a rim, so that the interaction of the rim andthe recess on the weighing platform creates a labyrinth gasket that isat least splash-proof.

According to another variant of the invention, the star feeder isarranged at a distance parallel to the test chamber floor, by the heightof the weighing platform above the floor, whereby at least one plate canbe placed onto the floor whose thickness matches the height of theweighing platform above the test chamber floor, and whereby the platehas recesses for the discharge opening, the weighing platform, thepassage for the drive shafts of the star feeder and the like.

According to another variant of the invention, the load cell of thescales can be arranged directly below the weighing platform.

According to another variant of the invention, the test chamber floorhas a rim around the discharge opening.

According to another variant of the invention, the discharge opening canbe sealed by a plug.

According to another variant of the invention, electric and/or opticalconnections for connecting a computer or the like for functionmonitoring and for detecting and forwarding the test data are arrangedin or on the wall of the housing inside the additional chamber separatedby the hinged door, that is to say, the antechamber, whereby thecomputer can be arranged in this chamber.

According to another variant of the invention, the protective hood canonly be opened or locked after the hinged door on the test chamber floorhas been opened.

According to another variant of the invention, the interior of thehousing that forms the receiving chamber can be charged with a constantpositive pressure relative to the environment and/or the test chamber.

According to another variant of the invention, the test chamber can becharged with a constant negative pressure relative to the environment.

According to another variant of the invention, the device consists of ahousing with a closeable test chamber that is arranged above saidhousing and that is formed by a floor and by a moveable protective hoodthat can be placed onto this floor, whereby the testing means as well asthe transporting means are located in said chamber, whereby the drivesand, if applicable, supply means for the testing means and thetransporting means that are arranged in the test chamber are, in turn,located in the separate housing encapsulated so as to be water-tight anddust-tight vis-à-vis the test chamber and, if applicable, also vis-à-visthe environment.

In an advantageous embodiment of the invention, at least parts of thefeed lines leading to the drives and to the supply means that provideenergy to the testing means as well as to the transporting means insidethe housing pass to the outside of the test chamber in a manner so as tobe water-tight and dust-tight. In another embodiment of the invention,all of the passages through the floor that serve to pass the feed linesthrough and that serve to accommodate the testing means are equippedwith water-tight gaskets which can be, for instance, inflatable O-ringgaskets.

In comparison to the state of the art, the device according to theinvention for the quality control of solid, pharmaceutical productsentails the advantage that the drives and supply lines as well as thesignal amplifiers for all of the devices for singling, transporting andtesting the products arranged in a test chamber that can be closed by aprotective hood are accommodated in housings that are splash-proof orwater-tight and dust-tight vis-à-vis the test chamber, so that, forinstance, cleaning work involving cleaning solutions, power washers andthe like can be carried out quickly and simply, whereby the lines thatsupply energy to the drives, supply means and signal amplifiers from thesealed housings to the outside of the test chamber are configured so asto be splash-proof or water-tight.

In an advantageous embodiment of the invention, the feed lines leadingto the drives and, if applicable, to the supply means that provideenergy to the testing means and to the transporting means pass throughthe test chamber floor into the receiving chamber that is located belowthe sealed test chamber and that is formed by the housing, so that thedevice is divided by the test chamber floor into the test chamber, onthe one hand, and into the receiving chamber of the housing, on theother hand, whereby the housing that encloses the receiving chamber canbe closed by a door or the like so as to be water-tight and dust-tight,and means for driving, controlling and supplying the testing means andthe transporting means, such as drive aggregates, electric motors,electric controls, signal amplifiers as well as electric and/or opticaland/or mechanical connections for supplying energy to the testing meansare all arranged inside the receiving chamber. In this manner, thedevice can be cleaned completely, thoroughly and especiallyautomatically. In order to do so, after the device has been used for itsintended purpose, all inlet or feed openings as well as all outlet ordischarge openings are hermetically sealed so as to be water-tight, andso are all of the passages through the floor of the sealed test chamber,for instance, by O-rings which, in a special embodiment, can also beinflatable. Thus, the test chamber can be made as water-tight as anaquarium. Then water is filled into the test chamber and the drives ofthe device are turned on, so that all of the rotating parts or partsthat move back and forth inside the sealed test chamber move within thewater bath, as a result of which they perform an automatic cleaningprocedure. Subsequently, if necessary, the device can be brought to aclean room.

In another advantageous embodiment of the invention, the housing of thereceiving chamber, preferably in the front outer wall of the housing,has at least one interface that is accessible from outside of thehousing and that serves to establish a connection for electric and/oroptical and/or mechanical connections for supplying energy to thetesting means and for connecting a computer or the like for functionmonitoring and for detecting and forwarding test data from the sensors,so that the device can be controlled and its function can be monitoredand the test data can be evaluated irrespective of the set-up locationof the device and of any cleaning work that might be necessary. Theinterface eliminates the need for passages for cables and the likethrough the housing wall, thus ensuring that the device can beconfigured so as to be water-tight and dust-tight. Therefore, the testchamber floor as well as the protective hood extend beyond the housingof the receiving chamber on at least one side, preferably on the frontof the housing, whereby a hinged door is arranged on the housing and itseparates another chamber below the test chamber floor and between thefront of the housing located across from the hinged door, into whichchamber the interface opens that is accessible from the outside.

In an advantageous embodiment of the invention, the protective hoodseals the test chamber vis-à-vis the environment so as to be water-tightand dust-tight in order to prevent abrasion dust or the like from beingdischarged out of the test chamber, and the protective hood can belocked and pressed onto the test chamber floor.

In another embodiment of the invention, the protective hood has anencircling gasket on its surface facing the test chamber floor, so thata tight seal can be attained when the protective hood is pressed down,as a result of which dirt or residues of tested products on the contactsurface between the test chamber floor and the protective hood cannothave a detrimental impact on the sealing of the test chamber vis-à-visthe environment.

In another advantageous embodiment of the invention, the receivingchamber only occupies part of the surface area below the test chamberfloor, so as to create an additional chamber that is separated from theenvironment by a door or the like and that is water-tight and dust-tightvis-à-vis the receiving chamber into which the externally accessibleinterface of the receiving chamber opens up. The tested products can becaptured through a discharge opening in the test chamber floor in acollecting container arranged below the test chamber floor.

In an advantageous embodiment of the invention, the transporting meansis a driven star feeder that rotates around its vertical central axisand that, on its outer circumference, has at least one receiving cellthat is open towards the test chamber floor to accommodate a product tobe tested, whereby the rotation of the star feeder causes the productscontained in the cells to be conveyed to various testing means, and thetests are carried out on the product in the receiving cell lying on thetest chamber floor, so that, as the star feeder rotates further, theproduct can be conveyed to another testing means and ultimately reachesthe discharge opening and falls through it.

In another advantageous embodiment of the invention, the dischargeopening opens up into the chamber that is separated from the receivingchamber and from the environment so as to be water-tight and dust-tight,whereby said chamber can be locked by a hinged door or the like, and theexternally accessible interface of the receiving chamber can also bereached from there.

An especially advantageous embodiment of the invention provides that,particularly in order to render the arrangement of the scales in thetest chamber water-tight, the weighing platform is placed at an elevatedposition above the test chamber floor. Below the weighing platform, thetest chamber floor has a rim that, together with the weighing platformfitted with a recess to receive the rim, forms a labyrinth gasket thatis liquid-tight and dust-tight, so that no cleaning solution canpenetrate the housing located underneath. At the same time, the rim canserve to limit the path of the weighing platform, so that the sensitivescales cannot be overloaded during the cleaning procedure. Moreover,this arrangement makes it possible to remove the weighing platform inorder to perform maintenance work and the like, for instance, to cleanthe guide of the stamp used to press the weighing platform onto the loadcell. The drive shaft of the star feeder can likewise be sealed by meansof a rim although, in an advantageous manner, instead of or in additionto the rim, an axially sealing bearing is employed so that the driveshaft can pass through the test chamber.

In another particularly advantageous embodiment of the invention, inorder to allow the feed of the test objects via a star feeder onto theweighing platform located above the test chamber, at least a single-partor multi-part plate is laid onto the test chamber floor between thelatter and the star feeder, said plate having openings for the driveshaft of the star feeder, the weighing platform, the discharge openingfor the test objects and, if applicable, for other test means and forthe drive of the loading means, whereby the thickness of said platematches the installation height of the weighing platform above the testchamber floor. Both the star feeder and the plate located below it canbe lifted off so as to facilitate, for example, cleaning work once thesecomponents have been removed.

In an advantageous embodiment of the invention, the load cell of thescales is arranged directly below the weighing platform so that itbecomes possible to dispense with sealing the passage for the stamp ofthe weighing platform that presses onto the load cell, so that only theelectric, and optionally, optical connections of the load cell with thesignal amplifiers inside the housing have to pass through the housingwall.

In an advantageous embodiment of the invention, the discharge opening isfitted with a rim that prevents cleaning solution from flowing outthrough the discharge opening, whereby the height of the rim above thetest chamber floor is less than the distance between the bottom of thestar feeder and the test chamber floor.

In another advantageous embodiment of the invention, the dischargeopening is designed so that it is closed or can be closed by a plugduring cleaning work and the like.

In another embodiment of the invention, in addition to the collectingcontainer, there is a computer or the like for recording and processingthe measured values arranged in the chamber that is separated from thereceiving chamber, that is accessible through the hinged door and thatis located below the test chamber floor, whereby, via electric and/oroptical connections arranged in the separation wall leading to thereceiving chamber, the computer can be connected to the signalprocessing means and to the signal amplifier of the scales, to thecontrols for the drives of the singling trough, the loading means andthe star feeder as well as, optionally, to additional measuring andtesting means that are connected to the weighing device.

In an additional advantageous embodiment of the invention, theprotective hood can be closed by a lock that can only be operated fromthe chamber located below the test chamber floor and accessible throughthe hinged door.

In an additional advantageous embodiment, a constant negative pressureis generated in the receiving chamber below the test chamber, so that aconstant stream of air exits through any gaps that might be present atthe passages for the drive shafts and the like in the housing,particularly during the cleaning procedure.

In another advantageous embodiment of the invention, a constant negativepressure is maintained in the test chamber so as to prevent abrasiondust or the like from escaping from the test chamber during the testingof, for instance, hormone products or antibiotics.

In another advantageous embodiment of the device, the housing, which ishermetically sealed vis-à-vis the test chamber, along with the receivingchamber that is enclosed by the housing, is arranged next to the testchamber floor instead of below it.

According to another variant of the invention, the device consists of ahousing and of a closeable test chamber arranged above said housing, thechamber being formed by a floor and by a movable protective hood thatcan be placed onto this floor, where both the testing means and thetransporting means are located, whereby the drives and, if applicable,supply means for the testing means and the transporting means that arearranged in the test chamber are arranged in the separate housing thatis encapsulated so as to be water-tight and dust-tight, if applicable,also vis-à-vis the environment.

According to another variant of the invention, at least parts of thefeed lines leading to the drives and the supply means that provideenergy to the testing means and to the transporting means inside thehousing are encapsulated so as to be water-tight and dust-tight as theypass to the outside of the test chamber.

According to another variant of the invention, the passages through thefloor for passing through the feed lines as well as for receiving thetesting means are configured with water-tight gaskets.

According to another variant of the invention, the device has a singlingmeans as the transporting means arranged inside the test chamber, towhich singling means the pharmaceutical products can be fed from astorage container, whereby the device has another transporting meansarranged above the test chamber floor that has at least one receivingcell that is open towards the floor into which one product from thesingling means can be introduced, whereby the product in the receivingcell can be fed to at least one testing means preferably located belowthe transporting means for checking the product in terms of its weightand/or dimensions and/or hardness and/or abrasion properties, and theproduct, after the checking procedure and during the further course oftransportation, can be removed from the receiving cell through adischarge opening into which the product falls and that is locateddownstream from the testing means, whereby a collecting container issituated below the discharge opening and it serves to receive the testedproducts or parts thereof.

According to another variant of the invention, the testing means is aset of scales equipped with a weighing platform and a load cell, wherebythe weighing platform is arranged above the test chamber floor and thefloor has a water-tight gasket under the weighing platform or inside theweighing platform.

According to another variant of the invention, the floor below theweighing platform has a rim, whereby the weighing platform has a recessto receive the rim, so that the interaction of the rim and the recess onthe weighing platform creates a water-tight gasket, especially alabyrinth gasket.

According to another variant of the invention, the drives and, ifapplicable, supply means for the testing means and the transportingmeans that are arranged in the test chamber are arranged in a separatehousing encapsulated so as to be splash-proof and dust-proof at leastvis-à-vis the test chamber and the environment, whereby at least partsof the feed lines leading to the drives and the supply means thatprovide energy to the testing means inside the housing are likewiseencapsulated so as to be splash-proof and dust-tight as they pass to theoutside of the test chamber.

According to another variant of the invention, the housing, which ishermetically sealed vis-à-vis the test chamber, along with the receivingchamber that is enclosed by the housing, is arranged next to the testchamber floor instead of below it.

BRIEF DESCRIPTION OF THE DRAWINGS, WHERE THE FOLLOWING IS SHOWN

FIG. 1 a front view of a device according to the invention;

FIG. 2 a side view of the device of FIG. 1 rotated clockwise by 90°;

FIG. 3 a top view of the device of FIG. 1;

FIG. 4 a top view of the device of FIG. 1 once the protective hood hasbeen removed;

FIG. 5 a perspective view of the device of FIG. 1 with a singling means,loading means, star feeder and closed protective hood as well as aclosed hinged door;

FIG. 6 a perspective view of the device of FIG. 1 with an openprotective hood, whereby the hinged door is not shown;

FIG. 7 a perspective front view of the device of FIG. 1 when the frontwall has been removed, whereby the protective hood is not shown, whilethe hinged door is only partially shown; and

FIG. 8 a perspective top view of the device of FIG. 1 with an openprotective hood, whereby the singling means and the star feeder are notshown, while the loading means is only partially shown.

The figures are merely schematic depictions.

DESCRIPTION OF THE EMBODIMENT

The device 17 for the quality control of solid pharmaceuticalproducts—which is shown in a front view in FIGS. 1, 2 and 3, in a sideview rotated clockwise by 90° and in a top view—consists of a cuboidhousing 2 and it has a test chamber 15 closed by a transparent hood 1,whereby the front of the hood has a handle 13 for lifting off andswiveling the protective hood 1. Likewise, the upper covering surface ofthe protective hood 1 has an opening 12 through which the pharmaceuticalproducts enter the test chamber 15.

The test chamber 15 is separated from the housing 2 by a test chamberfloor 4 so that a water-tight and dust-tight receiving chamber 16 iscreated below the test chamber floor 4 of the device 17 inside thehousing 2, said receiving chamber 16 serving to accommodate thenecessary controls and drives of the means that are present in the testchamber and that are used for singling, transporting and testing pills,tablets or the like. Likewise arranged in the receiving chamber 16 aresignal amplifiers for the testing means used to measure, for example,the weight, dimensions and hardness and these are likewise encapsulatedso as to be water-tight.

A hinged door 13, which is installed on the front of the housing 2 ofthe device 17, closes the receiving chamber 16 that is separatedwater-tight and dust-tight inside the housing 2 and that is below thetest chamber floor 4 of the device 17, said receiving chamber 16 beingable to accommodate, for example, a computer or the like for purposes ofacquiring test data. The front wall 19 of the housing 2 is recessed withrespect to the test chamber floor 4, as depicted in FIG. 2, so that afree space 20 separated by the hinged door 3 is formed between thehinged door 3 and the front wall 19 of the housing 2, and a collectingcontainer 18 for the tested products is arranged in said free space 20.In order to cover the collecting container 18 and to form the free space20, the hinged door 3 is angled at both ends, so that the hinged door 3has a double-L shape as seen from above.

Inside the front wall 19 of the housing 2, there is also an interface(not shown here) for the connection of all electric, mechanical orpneumatic aggregates. Except for the protective hood 1, the device ispreferably made of stainless steel.

FIG. 4 shows a top view of a device according to the invention for thequality control of solid pharmaceutical products when the protectivehood 1 has been removed. The products to be tested, for instance,tablets, are fed from a storage container (not shown here)—which can belocated inside or outside of the test chamber 15—to a singling means 5which, in the example shown, is a shaking trough 5 that is driven by anelectric motor 14. At the end of the singling means 5, the products fallindividually into a loading means 6. This loading means 6 can be rotatedaround an axis and it feeds the tablets individually to a rotatable starfeeder 7 that has several receiving cells 8 distributed peripherallyalong its circumference. Between the star feeder 7, which can be liftedoff in the direction of the observer, and the test chamber floor 4,there is a plate that can likewise be lifted off in the direction of theobserver and that has recesses for the drive shaft that imparts theswiveling movement of the loading means 6, for the drive shaft of thestar feeder 7, for the scales 9 and for the discharge opening 10. In thearea around the loading means 6, the plate is elevated by the thicknessof the star feeder 7, so that the loading means 6 is positioned flushabove the star feeder 7 and the products can be pushed by the loadingmeans 6 over the edge of the star feeder 7 in such a way that they fallfrom the top into the receiving cells 8 of the star feeder 7. Thereceiving cells 8 are holes and are thus open in the direction of thetest chamber floor 4.

As a result of the clockwise rotational movement of the star feeder 7around its central axis perpendicular to the plane of observation, thetablets are fed via a weighing platform 9 that is raised with respect tothe test chamber floor 4 by the thickness of the plate positionedbetween the star feeder 7 and the test chamber floor 4 to a set ofscales that are arranged in the housing 2 and that are flush with theplate. Subsequently, the weighed products are conveyed by the rotationalmovement of the star feeder 7 to a discharge opening 10 through whichthey fall into the collecting container 18 positioned behind the hingeddoor 3.

In order to configure the receiving chamber 2 water-tight, for example,the electric motor 14 of the singling means 5 is in a rectangular pipe11 that has been welded onto the test chamber floor 4 and that is closedin the direction of the observer, so that only the passages for thedrive shafts and for the stamp that is arranged below the weighingplatform 9 and that presses onto the load cell of the scales passthrough the receiving chamber 3 which can otherwise be closed so as tobe water-tight and dust-tight.

For the cleaning procedure, according to the method, all of the feed anddischarge openings or inlet and outlet openings are hermetically sealedso as to be water-tight, except for one opening through which air can bevented. Then water is filled into the test chamber 15, for example,using a hose connection provided for this purpose, and then the openingfor venting air out of the test chamber 15 is likewise closed. Now allof the movable aggregates such as the shaking trough 5, star feeder 7,loading means 6, in certain cases also the drive shaft for the swivelingmovement of the loading means 6 are put into motion inside the waterbath by their drive aggregates, so that the movement of the aggregatesinside the water bath creates a vigorous turbulence, which results in athorough cleaning. After the water has been drained, an air dryingprocedure can be carried out with hot air that is simultaneously fed invia the feed opening and blown out via the discharge opening.

FIG. 5 shows a schematic perspective view of the device 17 of FIG. 1with the singling means 5, the loading means 6, the star feeder 7 andthe closed protective hood 1 as well as the closed hinged door 3. Thehinged door 3 is joined to the housing 2 by means of hinges S1.

According to the invention, the device 17 serves for the quality controlof solid pharmaceutical products such as tablets, pills, oblongs and thelike. The housing 2 is arranged below the test chamber 15 that can beclosed so as to be splash-proof or water-tight and dust-tight vis-à-visthe environment, said chamber 15 being formed by the floor 4 and by theprotective hood 1 that can be placed onto and lifted off this floor.

The floor 4 of the test chamber 15 concurrently forms the upper wall ofthe housing 2 and of the antechamber 20 located between the hinged door3 and the housing, as a consequence of which it is not visible in FIG.5. The handle 13 that serves to open the protective hood 1 is not shownin FIG. 5.

The protective hood 1 is joined to the housing by means of hinges S2 andit is pressed onto the floor 4 by means of locks V so as to bewater-tight and dust-tight. For this purpose, the locks V each have anextension that is capable of exerting pressing force in the direction ofthe floor 4 onto a projection arranged on the inside of the front wall 1a of the protective hood 1. These extensions and projections are notshown in the figures. The locks V can be activated and deactivated bymeans of control elements (which are likewise not shown), that is tosay, the protective hood can be locked and unlocked by means of thecontrol elements. For the sake of easier handling, the housing 2 hasside handles G.

In order for the pharmaceutical products to be tested, they areintroduced into the singling means 5 via the filling opening. The modeof operation of such a singling means is described in German patent DE38 64 82.2.

The electric motor 14 is secured on a stand by means of the rectangularpipe 11.

The loading means 6 has an encircling element 6 a with an indentation 6b, a loading shaft 6 c and a plate-like substrate 6 d. The encirclingelement 6 a is affixed to the loading shaft 6 c so that it cannotrotate. The singling means 5 is arranged on the electric motor 14 insuch a way that the singled products fall out of the singling means 5individually one at a time into an indentation 6 b of the encirclingelement 6 a that is open towards the top and the bottom.

Below the indentation 6 b, there is an impact sensor 6 e (not depictedin FIG. 5; see FIG. 8) that detects the fall of a product into theindentation 6 b and, by means of another electric motor (not shownhere), imparts a loading shaft 6 c with such a swiveling movement thatthe indentation 6 b moves above a receiving cell 8 of the star feeder 7that is open towards the top and the bottom. The star feeder 7 can berotated in increments by means of a rotation shaft 7 a. Here, therotational movement of the star feeder 7 is synchronized with theswiveling movement in such a way that, at the end of every swivelingmovement, the indentation 6 b is positioned above one of the receivingcells 8. The product is thus transported by the swiveling movement fromthe impact sensor 6 a over the substrate 6 d to a receiving cell 8 andfalls into it. This procedure is repeated every time when one of theproducts to be tested falls into the indentation 6 b. The tops of theimpact sensor 6 e, of the substrate 6 d and of the star feeder 7 arepreferably on the same level.

In the present example, the testing of the pharmaceutical productconsists of a weighing procedure. The star feeder 7 rotates once theproduct has fallen into the receiving cell, in this manner conveying theproduct to the scales 9, which are not shown in FIG. 5 and, aftercompletion of the weighing procedure, to the discharge opening 10 (notshown in FIG. 5) arranged below the star feeder 7, so that the productfalls through the opening and reaches the collecting container 18.

The singling means 5, the loading means 6 and the star feeder 7 togetherform a transporting means for the products. Naturally, other parametersof the individual pharmaceutical product can be tested or measured suchas, for instance, the height and the rupture strength of the productbefore it is fed to the discharge opening 10.

According to the invention, the test chamber 15 can be closed so as tobe splash-proof or water-tight and dust-tight. In particular, this isextremely advantageous if the test chamber 15 is to be cleaned, forinstance, by being rinsed, after environmentally toxic or healthhazardous pharmaceutical products have been tested with the device 17since this ensures that no residues or dust from the product can reachthe environment in an uncontrolled manner. In the case of a water-tightversion, it is advantageously possible to even completely flood the testchamber 15.

FIG. 6 shows a perspective view of the device 17 when the protectivehood 1 is completely open, whereby the hinged door 3 of FIG. 5 is notshown. Therefore, the antechamber 20 can be clearly seen in FIG. 6. Inthe example of FIG. 6, the front wall 19 of the housing 2 consists of anencircling frame 23 and a front plate 21 that is placed onto it andaffixed by means of screws 21 a. According to a preferred embodiment ofthe invention, the housing 2 is likewise configured in such a way thatit can be closed so as to be splash-proof or water-tight and dust-tight.Therefore, the front plate 21 is preferably placed onto the frame 23 ina manner that is splash-proof or water-tight and dust-tight. In FIG. 6,the protective hood 1 is shown swiveled on the hinge S2 towards theback.

FIG. 7 shows a perspective front view of the device 17 when the frontwall 21 has been removed, whereby the protective hood 1 is not shownwhile the hinged door 3 is only partially shown. An encircling gasket 23a runs along the inside of the frame 23, said gasket serving to seal offthe front plate 21 with respect to the frame 23. Likewise arranged onthe frame 23 opposite from the hinges S1 is a closing mechanism 24 thatserves to lock the hinged door 3 in the closed position.

FIG. 8 shows a perspective top view of the device 15 when the protectivehood is open, whereby the singling means 5 and the star feeder 7 are notshown while the protective hood 1 as well as the loading means 6 areeach only partially shown. The protective hood 1 is completely open andis located in the position already shown in FIG. 6. The front surface 1c of the protective hood 1 that points downwards when the protectivehood 1 is in the closed position and therefore faces the floor 4 has anencircling gasket 1 b that is capable of sealing off the front surface 1c so that it is splash-proof or water-tight and dust-tight with respectto the floor 4.

The star feeder 7 is not shown in FIG. 8, as a result of which there isa clear view of the rotation shaft 7 a as well as of the scales 9 andthe discharge opening 10. By the same token, the encircling element 6 aand the substrate 6 d of the loading means are not shown in FIG. 8, sothat the part of the pivot shaft 6 c that protrudes towards the topabove the floor 4 and the impact sensor 6 e are completely visible.

INDUSTRIAL APPLICABILITY

The subject matter of the invention can be used, especially in thepharmaceutical industry, for checking and processing as well as handlingpharmaceutical products such as tablets. The special usefulness lies inthe fact that the device is capable of operating in a completelyhygienic manner and does not affect at all the clean processing of thenext product to be processed, particularly when a switch is made withinthe device to a different medication or different pills, since thedevice can be optimally cleaned prior to switching over to the nextproduct to be processed.

LIST OF REFERENCE NUMERALS

-   1 protective hood-   1 a front of 1-   1 b gasket of 1-   1 c lower front surface of 1-   2 housing-   3 hinged door-   4 test chamber floor-   5 singling means-   6 loading means-   6 a encircling element of 6-   6 b indentation of 6-   6 c swivel shaft of 6-   6 d substrate of 6-   6 e impact sensor of 6-   7 star feeder-   7 a rotation shaft of 7-   8 receiving cell-   9 scales-   10 discharge opening-   11 rectangular pipe-   12 filling opening-   13 handle for opening the protective hood-   14 electric motor-   15 test chamber below the protective hood 1-   16 receiving chamber of the housing 2-   17 device-   18 collecting container-   19 front wall of the housing 2-   20 antechamber-   21 front plate-   21 a screws-   22 interface-   23 frame-   24 closing mechanism-   G handle-   S1,S2 hinge-   V locks

1. A device (17) for the quality control of solid pharmaceuticalproducts comprising at least one testing means (9) having at least onesensor—and/or a height measuring means and/or a force measuring meansfor measuring the rupture strength of the product—for checking andascertaining one or more parameters of the individual pharmaceuticalproduct as well as comprising a transporting means (5, 6, 7) for theproducts, characterized in that the device (17) has a housing (2) and atest chamber (15) that is arranged above said housing and that can besealed so as to be splash-proof or water-tight and dust-tight vis-à-visthe environment, said chamber being formed by a floor (4) and by aprotective hood (1) that can be placed onto and lifted off this floor,whereby the testing means (9) as well as the transporting means (5, 6,7) are located in said chamber.
 2. The device according to claim 1,characterized in that all of the lines and/or drive shafts (6 c, 7 a)leading into or out of the test chamber (15) are configured so as to besplash-proof or water-tight and dust-tight as they pass through theprotective hood (1) or the floor (4).
 3. The device according to claim2, characterized in that the floor (4) has at least one passage,especially for passing lines or a drive shaft (6 c, 7 a) through, saidpassage being sealed by means of a gasket that is splash-proof orwater-tight and dust-tight.
 4. The device according to claim 1,characterized in that the protective hood (1) can be pressed onto theperiphery of the floor (4) of the test chamber (15) and locked in placeso as to be splash-proof or water-tight and dust-tight, whereby theprotective hood (1) has an encircling gasket (1 b) that is splash-proofor water-tight and dust-tight on its surface (1 c) facing the floor (4)of the test chamber (15).
 5. The device according to claim 4,characterized in that the gaskets are inflatable O-ring gaskets.
 6. Thedevice according to claim 1, characterized in that an interface (22)that is accessible from outside of the housing (2) is arranged on thehousing (2), preferably on its front wall (19), whereby a plurality ofelectric lines leading into or out of the housing (2) open into saidinterface and the latter serves to establish an electric connection forthe device (7) and/or to transmit electric signals and/or data betweenthe device (7) and the outside world.
 7. The device according to claim6, characterized in that a hinged door (3) is arranged on the housing(2) in such a way as to form an antechamber (20) between the housing (2)and the hinged door (3).
 8. The device according to claim 7,characterized in that the discharge opening (10) is a hole in the floor(4) of the test chamber (15), and the collecting container (18) islocated in the antechamber (20).
 9. The device according to claim 1,characterized in that the device (17) encompasses the followingadditional components: a singling means (5) as part of the transportingmeans (5, 6, 7) arranged inside the test chamber (15), whereby thepharmaceutical products can be fed from the storage container to thesingling means; a conveying means (7) as another part of thetransporting means (5, 6, 7) that is arranged above the test chamberfloor (4) and that has at least one receiving cell (8) open towards thefloor (4) into which one product from the singling means (5) can beintroduced, whereby the product accommodated in the receiving cell (8)can be fed to the testing means (9); a discharge opening (10) to whichthe product—after it has been tested by the testing means (9)—can be fedduring the further course of transportation by the conveying means (7),whereby the product reaches the discharge opening (10) and then fallsthrough it, as a result of which it is removed from the receiving cell(8); as well as a collecting container (18) situated below the dischargeopening (10) that serves to receive the tested products or parts thereofonce they have fallen through the discharge opening (10).
 10. The deviceaccording to claim 9, characterized in that the transporting means (7)is a star feeder (7) that is arranged parallel to the floor (4) and thatcan rotate around a vertical axis, the receiving cell (8) is situated inthe vicinity of the outer circumference of the star feeder (7), and thetesting means (9) as well as the discharge opening (10) are arranged insuch a way that, as the star feeder (7) turns in its direction ofrotation, each product accommodated inside the receiving cell (8) firstreaches the testing means (9) and subsequently the discharge opening(10).
 11. The device according to claim 9, characterized in that thetest chamber floor (4) has a rim around the discharge opening (10). 12.The device according to claim 1, characterized in that the protectivehood (1) can be connected in a detachable manner to the floor (4) of thetest chamber (15) so as to be splash-proof or water-tight anddust-tight.
 13. The device according to claim 1, characterized in thatthe housing (2) can likewise be sealed so as to be splash-proof orwater-tight and dust-tight.
 14. The device according to claim 1,characterized in that means for driving, controlling and supplying oneor more testing means (9) and one or more transporting means (5, 6, 7)are arranged in the housing (2).
 15. The device according to claim 1,characterized in that all inlet or feed openings (12) leading into thetest chamber (15) as well as all outlet or discharge openings (12)leading out of the test chamber (15) can be hermetically sealed so as toensure that the test chamber (15) is splash-proof or water-tight. 16.The device according to claim 1, characterized in that the floor (4) ofthe test chamber (15) is, at the same time, the wall of the housing (2).17. The device according to claim 1, characterized in that means fordriving, controlling and supplying the testing means (9) and thetransporting means (5, 6, 7), such as drive aggregates, electric motors,electric controls, signal amplifiers as well as electric and/or opticaland/or mechanical connections to supply energy to the testing means (9)are all arranged inside the housing (2).
 18. The device according toclaim 1, characterized in that the testing means (9) is a set of scales(9) equipped with a weighing platform and a load cell.
 19. The deviceaccording to claim 1, characterized in that the inside of the housing(2) can be charged with positive pressure relative to the environmentand/or to the test chamber (15).
 20. The device according to claim 1,characterized in that the test chamber (15) can be charged with negativepressure relative to the environment.
 21. The device according to claim1, characterized in that the housing (2) is situated next to the floorof the test chamber (15) rather than below it.
 22. The device accordingto claim 1, characterized in that the device has rollers or wheels onwhich the device (17) can be moved.
 23. The device according to claim 1,characterized in that the front wall (19) of the housing (2) consists ofa frame (22) and of a removable front plate (21) that can be placed ontothe frame so as to be water-tight.
 24. A device (17) for the qualitycontrol of solid pharmaceutical products selected from the groupconsisting of tablets, pills, oblongs and mixtures thereof, comprisingat least one testing means (9) having at least one sensor scale (9)and/or a height measuring means and/or a force measuring means formeasuring the rupture strength of the product—for checking andascertaining one or more parameters of the individual pharmaceuticalproduct as well as comprising a transporting means (5, 6, 7) for theproducts, characterized in that the device (17) has a housing (2) and atest chamber (15) that is arranged above said housing and that can besealed so as to be splash-proof or water-tight and dust-tight vis-à-visthe environment, said chamber being formed by a floor (4) and by aprotective hood (1) that can be placed onto and lifted off this floor,whereby the testing means (9) as well as the transporting means (5, 6,7) are located in said chamber.
 25. A device (17) for the qualitycontrol of solid pharmaceutical products comprising at least one testingmeans (9) having at least a member selected from the group consisting ofone sensor, a height measuring means and a force measuring means formeasuring the rupture strength of the product—for checking andascertaining one or more parameters of the individual pharmaceuticalproduct; a transporting means (5, 6, 7) for the products; a housing (2);a floor (4); a protective hood (1) that can be placed onto and liftedoff this floor, wherein the floor (4) and the protective hood (1) form atest chamber (15) that is arranged above said housing and that can besealed so as to be splash-proof or water-tight and dust-tight vis-à-visthe environment, wherein the testing means (9) as well as thetransporting means (5, 6, 7) are located in said test chamber.